Regarding an issue that affects anyone that uses a copier with a hard drive, Drinker Biddle partners Kenneth Dort and Mary Devlin Capizzi recently co-authored a client alert on “Photocopiers – A Recurring Data Security Risk.” The alert examines a recent settlement between the United States Department of Health and Human Services (HHS) and Affinity Health Plan, Inc. over an investigation into possible HIPPA privacy and security violations. Affinity self-reported a breach after a copier previously leased by the company was later purchased by CBS and it was found that confidential medical information was still present on the copier’s hard drive. In the alert, available here, Kenneth and Mary outline steps to safeguard against such security risks.

On Thursday, June 13th, the Supreme Court unanimously ruled that isolated and naturally occurring human genes cannot be patented. This case was brought to them by the American Civil Liberties Union (ACLU) who challenged Myriad Genetic, a molecular diagnostic company, over the right to patent BRCA1 and BRCA2 genes, which are used to test for breast and ovarian cancer. The test, though expensive, has been very successful in determining gene mutations that can lead to and cause these types of cancers.

In the majority opinion of the Court, Justice Clarence Thomas wrote: “Myriad found the location of the BRCA1 and BRCA2 genes. But that discovery, by itself, does not render the BRCA genes patent eligible.” The reasoning behind their ruling is that since Myriad only discovered the location of the gene, but did not create it, there is no basis for the company to claim ownership rights to something that already exists naturally. It would be like Polar Spring trying to patent spring water for their bottles— they might have found the springs but they did not make them. With this ruling, other human genes that are being researched, such as those that are linked to Alzheimer’s or other cancers, will not be allowed to be patented.1 The positive impact of this ruling is that it now opens up more companies, research facilities, and even universities to undertake their own testing with these and other genes. As more and more groups start testing diagnosis and treatments based on formally patented genes, it will not only increase the amount of research and discovery that can be done but, with an open market, it will cut down the cost for testing and treatment discovered with these genes.

The ruling was not all that bad for firms who want to patent genes. The Supreme Court stated in their ruling that though human and natural genes cannot be patented, synthetically created genetic material, or cDNA, can be. cDNA is more commonly used for the creation of protein-based drugs to fight these diseases.2 As time moves on, cDNA will become even more important for biotech firms for it will allow them to patent genes that they create which can be used to create drugs that will hopefully stop cancer. Though it will be some time before we can mass produce synthetic genes, for now the Supreme Court’s ruling stands and human genes are owned by no one.

Last night the Internal Revenue Service (IRS) announced that the enforcement of penalties under the Affordable Care Act’s (ACA’s) employer mandate will be delayed one year, and will go into effect in 2015 rather than 2014. Drinker Biddle Partner Sarah Bassler Millar and Counsel Dawn E. Sellstrom prepared the following client alert on the IRS’s decision.